Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing

This study is currently recruiting participants.

Verified by Soroka University Medical Center, May 2008

First Received: March 6, 2006 Last Updated: May 20, 2008 History of Changes

Sponsor:	Soroka University Medical Center
Information provided by:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT00299910

Purpose

This study will assess in a double blind placebo controlled fashion the effects of a 12 week course of oral montelukast/placebo on polysomnographic and radiological findings and will characterize the systemic (serum,urine) and local (upper airway collected biological samples) inflammatory response in children (2-10 years of age) with sleep disordered breathing, fittingthe inclusion and exclusion criteria.

Condition	Intervention	Phase
Sleep Disordered Breathing	Drug: Montelukast	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Inflammatory Response to Anti Inflammatory Therapy in Children With Sleep Disordered Breathing

Resource links provided by NLM:

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Estimated Enrollment:	50
Study Start Date:	March 2005

Eligibility

Ages Eligible for Study:	2 Years to 10 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:2-10 years old

1<AHI<8 measured in an overnight PSG

Exclusion Criteria:

Asthma Previous use or allergy to montelukast Use of antibiotics in the previous 3 weeks Use of corticosteroids in the previous 3 months Craniofacial dysmorphism Genetic or metabolic defined illnesses Adenotonsillectomy or adenoidectomy in the past

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299910

Contacts

Contact: Aviv D Goldbart, MD, MSc

972-8-6403400

avivgold@bgu.ac.il

Locations

Israel
Pediatric Sleep Center, Soroka University Medical Center	Recruiting
Beer-Sheva, Israel
Contact: Aviv D Goldbart, MD, MSc 972-8-6403400 avivgold@bgu.ac.il

Sponsors and Collaborators

Soroka University Medical Center

Investigators

Principal Investigator:

Asher Tal, MD

Soroka University Medical Center

More Information

Publications:

Goldbart AD, Goldman JL, Veling MC, Gozal D. Leukotriene modifier therapy for mild sleep-disordered breathing in children. Am J Respir Crit Care Med. 2005 Aug 1;172(3):364-70. Epub 2005 May 5.

Study ID Numbers:	sor388505ctil
Study First Received:	March 6, 2006
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00299910 History of Changes
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Respiratory System Agents
Sleep Apnea Syndromes
Apnea
Hormone Antagonists
Respiration Disorders
Nervous System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents

Dyssomnias
Sleep Disorders
Pharmacologic Actions
Sleep Disorders, Intrinsic
Leukotriene Antagonists
Montelukast
Respiratory Tract Diseases
Therapeutic Uses

ClinicalTrials.gov processed this record on November 09, 2009